The company said the lots of the product have been found to potentially have a higher concentration of ibuprofen.

According to Tris, there is a remote possibility that infants, who may be more susceptible to a higher potency level of drug, and therefore may be more vulnerable to permanent NSAID-associated renal injury.

Adverse effects that be be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea.

Tris said they have received no reports of adverse events related to the lots of product recalled so far.

The product is used as a pain reliever/fever reducer and was packaged in 0.5 oz. bottles for the recalled lots listed below:

(Chart Courtesy: Tris Pharma, Inc.)

Reports show the affected lots of Infants' Ibuprofen Concentrated Suspension, USP (NSAID) 50 mg per 1.25 mL was sold to one customer.

The customer has been notified by Tris Pharma of the recall.

Wholesalers and retailers of the product should stop further distribution of the affected lots of Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL that is included in the recall.

Consumers with questions regarding this recall can contact Tris Customer Service at 732-940-0358 (Monday through Friday, 8:00am ET- 5:00pm PT) or via email at Customer Service Email.

Consumers are advised to contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of the product lots subject to this recall may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.